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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008028
Receipt No. R000009453
Scientific Title A Clinical Study on Hemodynamic Changes by the Low Dose of Tolvaptan in Heart Failure Patients
Date of disclosure of the study information 2012/06/01
Last modified on 2012/05/26

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Basic information
Public title A Clinical Study on Hemodynamic Changes by the Low Dose of Tolvaptan in Heart Failure Patients
Acronym A Study on Hemodynamic Changes by the Low Dose of Tolvaptan
Scientific Title A Clinical Study on Hemodynamic Changes by the Low Dose of Tolvaptan in Heart Failure Patients
Scientific Title:Acronym A Study on Hemodynamic Changes by the Low Dose of Tolvaptan
Region
Japan

Condition
Condition Heart Failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation on the Safety & Efficacy of Low dose of Tolvaptan to the Patients with Congestive Heart Failure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hemodynamic Changes, Change of Body Weight
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tolvaptan is administered from the dose of 3.75mg/day. The dose of tolvaptan can be stepwise increased to 7.5mg/day, then 15mg/day.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria The patients with heart failure of Nohria/Steavenson B & C who need Swan-Ganz catheter for hemodynamic monitoring.
Key exclusion criteria 1) the patient's s-Na >147mEq/L at the administration of tolvaptan
2) the patients showing shock
3) the patient's creatinine >3.0mg/dL
4) the patient showing allergy to tolvaptan
5) pregnant patient
6) the patient regarded as inappropriate for this clinical study by the principal investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Nunoda, M.D., Ph.D.
Organization Tokyo Women's Medical University Medical Center East
Division name Cardiovascular Division
Zip code
Address 2-1-10 Nishiogu, Arakawa-ku, Tokyo 116-8567
TEL 03-3810-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Nunoda. M.D., Ph.D.
Organization Tokyo Women's Medical University Medical Center East
Division name Cardiovascular Division
Zip code
Address 2-1-10 Nishiogu, Arakawa-ku, Tokyo 116-8567
TEL 03-3810-1111
Homepage URL
Email nunodagm@dnh.twmu.ac.jp

Sponsor
Institute Institutional Review Board, Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University Medical Center East
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京女子医科大学東医療センター

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 26 Day
Last modified on
2012 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009453

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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